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Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Calcipotriol plus hydrocortisone (LEO 80190)
LEO 80190 Vehicle
Hydrocortisone
Calcipotriol
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of psoriasis vulgaris involving the face
  • Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
  • An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
  • Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of ointment per week
  • Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

Exclusion Criteria:

  • Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
  • Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
  • PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
  • UVB therapy within the 2-week period prior to randomisation
  • Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the double-blind phase of the study)
  • Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
  • Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
  • Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
  • Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
  • Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face or on the intertriginous areas
  • Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
  • Known or suspected severe renal insufficiency or severe hepatic disorders
  • Known or suspected disorders of calcium metabolism associated with hypercalcaemia

Sites / Locations

  • Croatia - managed by CRO
  • Macedonia - managed by CRO
  • Slovenia - managed by CRO
  • Department of Dermatology and Allergy, University of Bonn
  • Czech Republic - managed by CRO
  • Hungary - managed by CRO
  • Latvia - managed by CRO
  • Poland - managed by CRO
  • Belgium - managed by CRO
  • The Netherlands - managed by CRO
  • Serbia - managed by CRO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

LEO 80190

LEO 80190 vehicle

Calcipotriol

Hydrocortisone

Arm Description

Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)

Ointment Vehicle

Calcipotriol 25 mcg/g in the ointment vehicle

Hydrocortisone 10 mg/g in the ointment vehicle

Outcomes

Primary Outcome Measures

Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase
The (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline (Visit 1) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline (Visit 1) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.

Secondary Outcome Measures

Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase
The assessment of the disease severity of the face was made using the 6-category scale below. Clear Almost clear Mild Moderate Severe Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.
Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase
"Success" was defined as a TSS score of 0 or 1. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured) The sum of the three scores constituted a TSS ranging from 0 to 12
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase
The (sub)investigator made an assessment of the disease severity of the intertriginous areas using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas. For subjects with a baseline severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas.
Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase
The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none = mild = moderate = severe = very severe Thickness 0 = none = mild = moderate = severe = very severe Scaliness 0 = none = mild = moderate = severe = very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS. "Success" was defined as a TSS score of 0 or 1.

Full Information

First Posted
June 3, 2008
Last Updated
August 2, 2021
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00691002
Brief Title
Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds
Official Title
Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 80190
Arm Type
Experimental
Arm Description
Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)
Arm Title
LEO 80190 vehicle
Arm Type
Placebo Comparator
Arm Description
Ointment Vehicle
Arm Title
Calcipotriol
Arm Type
Active Comparator
Arm Description
Calcipotriol 25 mcg/g in the ointment vehicle
Arm Title
Hydrocortisone
Arm Type
Active Comparator
Arm Description
Hydrocortisone 10 mg/g in the ointment vehicle
Intervention Type
Drug
Intervention Name(s)
Calcipotriol plus hydrocortisone (LEO 80190)
Intervention Description
Once daily application
Intervention Type
Drug
Intervention Name(s)
LEO 80190 Vehicle
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Type
Drug
Intervention Name(s)
Calcipotriol
Primary Outcome Measure Information:
Title
Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase
Description
The (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline (Visit 1) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline (Visit 1) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.
Time Frame
At Week 8 (end of treatment for double-blind phase)
Secondary Outcome Measure Information:
Title
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase
Description
The assessment of the disease severity of the face was made using the 6-category scale below. Clear Almost clear Mild Moderate Severe Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.
Time Frame
At Week 4
Title
Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase
Description
"Success" was defined as a TSS score of 0 or 1. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured) The sum of the three scores constituted a TSS ranging from 0 to 12
Time Frame
At Week 8 (end of treatment for double-blind phase)
Title
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase
Description
The (sub)investigator made an assessment of the disease severity of the intertriginous areas using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas. For subjects with a baseline severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas.
Time Frame
At Week 8 (end of treatment for double-blind phase)
Title
Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase
Description
The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none = mild = moderate = severe = very severe Thickness 0 = none = mild = moderate = severe = very severe Scaliness 0 = none = mild = moderate = severe = very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS. "Success" was defined as a TSS score of 0 or 1.
Time Frame
At Week 8 (end of treatment for double-blind phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of psoriasis vulgaris involving the face Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions) Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of ointment per week Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face Exclusion Criteria: Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation UVB therapy within the 2-week period prior to randomisation Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the double-blind phase of the study) Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face or on the intertriginous areas Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study Known or suspected severe renal insufficiency or severe hepatic disorders Known or suspected disorders of calcium metabolism associated with hypercalcaemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bieber, MD
Organizational Affiliation
Department of Dermatology and Allergy, University of Bonn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croatia - managed by CRO
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Macedonia - managed by CRO
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Slovenia - managed by CRO
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Department of Dermatology and Allergy, University of Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Czech Republic - managed by CRO
City
Warszawa
ZIP/Postal Code
02-019
Country
Poland
Facility Name
Hungary - managed by CRO
City
Warszawa
ZIP/Postal Code
02-019
Country
Poland
Facility Name
Latvia - managed by CRO
City
Warszawa
ZIP/Postal Code
02-019
Country
Poland
Facility Name
Poland - managed by CRO
City
Warszawa
ZIP/Postal Code
02-019
Country
Poland
Facility Name
Belgium - managed by CRO
City
Warszawa
Country
Poland
Facility Name
The Netherlands - managed by CRO
City
Warszawa
Country
Poland
Facility Name
Serbia - managed by CRO
City
New Belgrade
ZIP/Postal Code
11070
Country
Serbia

12. IPD Sharing Statement

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Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

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